October 10, 2025 – Update on FDA Lapse period of indefinite duration. Content current as of November 10, 2025 The US government was shut down on October 1, 2025, as Congress and the Administration failed to agree on annual funding bills for federal agencies, including the DHHS and the agencies within it. Thus the FDA […]
If your medical device is on the market in the US or you are planning to launch it soon, you will need to make modifications to your Quality Management System (QMS) as soon as possible. If your MedTech or Digital Health company is presently engaged with the FDA, or you are planning to do so […]
